Enforcement Report - Week of June 7, 2023
The CMDh1 has decided that hydroxyethyl starch (HES) solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented. This follows further reflection, in consultation with EU Member States, on whether it would be feasible to introduce new measures that would effectively reduce the risks with these medicines.
Partially hydrolysed polyvinyl alcohol (PVA) was evaluated as a pelletisation aid for the production of pellets with a high acetaminophen and metformin hydrochloride concentration (>70%, w/w). Mixtures with varying drug concentration and PVA/microcrystalline cellulose (MCC) ratios were processed via extrusion-spheronisation, either after addition of PVA as a dry powder or as an aqueous solution. Finally, high drug- loaded metformin pellets were coated with a methacrylic acid copolymer (Eudragit™ NM 30D) and evaluated for their sustained release potency in vitro and in vivo. The plasticity index of the wet mass increased by the addition of PVA to the formulation, which resulted in enhanced extrusion-spheronisation properties, even at a high drug load. Although the MCC concentration was successfully lowered by adding PVA, the inclusion of MCC in the formulation was essential to overcome problems related to the tackiness effect of PVA during extrusion. Overall, wet addition of PVA was superior to dry addition, as pellets with a higher mechanical strength and narrower particle size distribution were obtained. Pellets containing 87% (w/w) metformin hydrochloride were successfully layered with 20% (w/w) coating material, yielding sustained release pellets with a final drug load of 70% (w/w). In addition, the sustained release characteristics of the PVA-based pellets with a high drug content were confirmed in vivo as no difference with the Glucophage™ SR reference formulation was observed.
Formulators are constantly looking for novel excipients which provide specific properties to a formulation and which (preferably) can be used for a broad range of drug products. Although partially hydrolyzed polyvinyl alcohol (PVA), a water-soluble synthetic polymer, is already used as viscosity-enhancing or stabilizing agent in liquid dosage forms, its use as pharmaceutical excipient in oral solid dosage forms has been limited.
The objective of the present study was to formulate and evaluate buccal patches containing combination of lisinopril (LP) and hydrochlorothiazide (HCZ). Approach: Films were fabricated by solvent casting method, using combination of mucoadhesive polymers such as hydroxypropylmethyl cellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinyl alcohol (PVA) and polyvinyl pyrolidone (PVP) and ethyl cellulose (EC) as backing layer. The patches were evaluated for physicochemical characteristics such as weight, thickness, surface pH, folding endurance, bioadhesive strength, swelling index, drug content, tensile strength, elongation at break, mucoadhesion time, in vitro and ex
The aim of this study was to enhance the dissolution and bioavailability of telmisartan (TLM), a poorly water soluble drug by comilling approach. Physical mixtures of TLM and poly(vinyl alcohol) (PVA) were comilled in a planetary micro mill in a dry condition by varying process parameters such as drug to polymer weight ratio, ball-to-powder weight ratio, and rotational speed. The comilled products that offered cumulative percentage dissolution of TLM above 75% in 30 min (CG 1 and CG2). These samples were characterized using field emission scanning electron microscopy (FE-SEM), powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC) and Raman spectra analysis.